Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor… (NCT05400122) | Clinical Trial Compass
SuspendedPhase 1
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
Stopped: Drugs unavailable
United States12 participantsStarted 2022-09-09
Plain-language summary
One of the ways that cancer grows and spreads is by avoiding the immune system.NK cells are immune cells that kill cancer cells, but are often malfunctioning in people with colorectal cancer and blood cancers. A safe way to give people with colorectal cancer and blood cancers fresh NK cells from a healthy donor has recently been discovered. The purpose of this study is to show that using two medicines (vactosertib and IL-2) with NK cells will be safe and will activate the donor NK cells. NK cells and vactosertib are experimental because they are not approved by the Food and Drug Administration (FDA). IL-2 (Proleukin®) has been approved by the FDA for treating other cancers, but the doses used in this study are lower than the approved doses and it is not approved to treat colorectal cancer or blood cancers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must have one of the following:
* Histologically confirmed locally advanced or metastatic colon or rectal adenocarcinoma
* Histologically confirmed locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
* Relapsed or refractory hematologic malignancy
* Acute myeloid leukemia with measurable residual disease (MRD) relapse
* MRD relapse is defined as presence of ≥ 1 in 10-4 nucleated cells per European LeukemiaNet 2021 guidance \[49\]: (1) conversion of MRD negativity to MRD positivity, independent of the MRD technique, or (2) increase of MRD ≥1 log10 between any two positive samples measured in the same tissue (PB or BM) in patients with MRD-Low Level
* Patients will be eligible if they have declined or are ineligible for standard treatment options and if there is no standard approach to curative therapy per NCCN guidelines. Patients with solid tumors must have had progression on at least one standard line of therapy.
* Hematologic malignancies in the relapsed or refractory setting can include:
* Acute myeloid leukemia
* Myelodysplastic syndrome
* Acute lymphoblastic leukemia
* Chronic myeloid leukemia
* Chronic lymphocytic leukemia
* Non Hodgkin Lymphoma
* Hodgkin Lymphoma
* Myeloproliferative syndromes
* Plasma cell myeloma
* Subjects must have recovered from acute toxicities of prior chemotherapy or stem cell transplant. Any prior non-hematologic vita…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])